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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AT012282-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The goal of this observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. The main questions it aims to answer are:
Participants in the healthy group will be asked to do the following tasks:
Participants in the chronic low back pain group will be asked to do the following tasks:
The investigators propose to use multimodal ultrasound imaging to develop and validate a practical and inexpensive biomarker for lumbar myofascial pain, which shows sensitivity to change in relation to treatment. Myofascial pain (MP) is a frequent contributing factor to chronic low back pain (cLBP). It is associated with a range of tissue abnormalities, such as taught muscle bands, trigger points (TPs), and thoracolumbar fascia motion dysfunction, along with poor tissue elasticity. As a result, a composite biomarker for MP related to components of the syndrome is more likely to be plausible biologically, robust, and useful clinically for diagnosis and treatment. The investigators propose to study: 1. The echogenicity of latent and active trigger points, 2. The dynamic spatial-temporal tissue deformation quantified by strain tensors (compression, extension, and shear) in the thoracolumbar fascia and multifidus muscle, 3. The viscoelastic properties of the fascia and muscles measured by ultrasound shear wave elastography. In the R61 Phase (year 1 to 3) the investigators will use deep learning to integrate these measurements into a predictive biomarker and use established validation methods to test its ability to predict MP.
The investigators will determine the sensitivity and specificity of the biomarker to classify the myofascial components of pain, as well as the response to treatment (a diagnostic and predictive marker).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Normals | Participants with no chronic pain over a three-year timeframe. |
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| MP without TPs | Participants with chronic low back pain who are classified as having myofascial pain and no trigger points. |
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| MP with latent TPs | Participants with chronic low back pain who are classified as having myofascial pain and latent trigger points. |
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| MP with active TPs | Participants with chronic low back pain who are classified as having myofascial pain and active trigger points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no intervention. It is a phenotyping study only | Other | See above, this is only a phenotyping study but NIH required us to register it as a trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of one of four MP-related categories | Participants to be diagnosed as normal, MP without TPs, MP with latent TPs, and MP with active TPs as determined by standardized clinical examinations. | Study Visit 1 (week 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Substantial MP | The presence of substantial MP (e.g., # active TPs and pressure pain threshold below 6.5 N/cm2) as determined by the standardized clinical examinations. | Study Visit 1 (week 1) - Study Visit 2 (week 2) |
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Inclusion/Exclusion Criteria for Healthy Normals (n=40):
Inclusion Criteria CLBP:
Exclusion Criteria CLBP:
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The investigators are including healthy normal and cLBP subjects from ages 20 to 70.
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| Name | Affiliation | Role |
|---|---|---|
| Kang Kim, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kauffman Medical Building | Pittsburgh | Pennsylvania | 15213 | United States |
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